PoC in Rheumatoid Arthritis With Methotrexate

NCT ID: NCT00605735

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate

Detailed Description

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Conditions

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Rheumatoid Arthritis, NOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

Group Type EXPERIMENTAL

BMS-582949

Intervention Type DRUG

Tablets, Oral, 300 mg, once daily, 12 weeks

P1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, Oral, placebo, once daily, 12 weeks

Interventions

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BMS-582949

Tablets, Oral, 300 mg, once daily, 12 weeks

Intervention Type DRUG

Placebo

Tablets, Oral, placebo, once daily, 12 weeks

Intervention Type DRUG

Other Intervention Names

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P38 Inflamation

Eligibility Criteria

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Inclusion Criteria

* Must have a diagnosis of RA for at least 6 months
* Must be taking methotrexate for at least 3 months \& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
* Must have at least 6 swollen and at least 8 tender joints
* CRP above upper limit of normal or ESR \> 28 mm/hr
* Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication

Exclusion Criteria

* Any infection including TB, HIV, Hepatitis B or C
* Recent infection requiring antibiotics within 4 weeks
* History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
* Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Desert Medical Advances

Palm Desert, California, United States

Site Status

Orrin M. Troum,M D

Santa Monica, California, United States

Site Status

G. Timothy Kelly, Md

Las Vegas, Nevada, United States

Site Status

Health Research Of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

The Arthritis Group

Philadelphia, Pennsylvania, United States

Site Status

Arthritis Clinic

Jackson, Tennessee, United States

Site Status

Walter F Chase Md

Austin, Texas, United States

Site Status

Tacoma Center For Arthritis Research Ps

Tacoma, Washington, United States

Site Status

Local Institution

Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution

Capital Federal, Buenos Aires, Argentina

Site Status

Local Institution

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Site Status

Local Institution

České Budějovice, , Czechia

Site Status

Local Institution

Hradec Králové, , Czechia

Site Status

Local Institution

Prague, , Czechia

Site Status

Local Institution

Bordeaux, , France

Site Status

Local Institution

Chambray-lès-Tours, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Guadalajara, Jalisco, Mexico

Site Status

Local Institution

Guadalajara, Jalisco, Mexico

Site Status

Local Institution

Mexico City, Mexico City, Mexico

Site Status

Local Institution

Nuevo León, Nuevo León, Mexico

Site Status

Local Institution

Culiacán, Sinaloa, Mexico

Site Status

Local Institution

Cheonan, Choong Chung Nam-Do, South Korea

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Santiago de C., , Spain

Site Status

Local Institution

Vizcaya, , Spain

Site Status

Local Institution

Taichung, , Taiwan

Site Status

Local Institution

Taoyuan District, , Taiwan

Site Status

Countries

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United States Argentina Czechia France Mexico South Korea Spain Taiwan

Related Links

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Other Identifiers

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IM119-015

Identifier Type: -

Identifier Source: org_study_id

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